# K080386: Columbia 600 Electrode, Columbia 06 Leadwire

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Scientific Development, LLC
- Decided: May 30, 2008 after 107 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871222 (1987). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070807: Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes, Pepin Mfg., Inc. (2007) Summary page 1.

## Most influential descendants
- K083756: Guardian 150 Electrode (2009), 3 descendants of its own
- K121483: Reusable Cutaneous Electrode (2012), 1 descendant of its own
- K172887: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (2018), 0 descendants of its own
- K113375: Eswallow Usa Electrode,Eswallow Usa Leadwire (2013), 0 descendants of its own

## Indications for use
The Columbia Scientific, Inc. cutaneous electrotherapy and recording electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. b) Electrical muscle stimulation (EMS) for neck muscle stimulation c) Functional electrical stimulation (FES). d) Galvanic stimulation. e) Microcurrent electrical nerve stimulation (MENS). f) Interferential stimulation. g) Neuromuscular electrical stimulation (NMES).

Source page: https://510kreport.com/device/K080386
Methodology: https://510kreport.com/methodology